FDA 510(k) Application Details - K020554

Device Classification Name Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

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510(K) Number K020554
Device Name Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant KINETIKOS MEDICAL, INC.
4329 GRAYDON RD.
SAN DIEGO, CA 92130 US
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Contact FLOYD G LARSON
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Regulation Number 888.3800

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Classification Product Code JWJ
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Date Received 02/20/2002
Decision Date 05/03/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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